Australia Updates Permissible Ingredients in Listed Medicines, Involving Vitamin and Herbal Supplements

On March 1, 2024, Therapeutic Goods Administration (TGA) of Australia published a notice to announce the issuance of Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024, replacing the previous instrument. Major changes involve the addition of 3 new ingredients and the revision of requirements for 37 ingredients. The new determination took effect on March 1, 2024.

Background

In Australia, vitamin and herbal supplements are regulated as complementary medicines by the TGA. Most complementary medicines are included in the Australian Register of Therapeutic Goods (ARTG) as listed medicines. Those medicines may only contain ingredients from an approved list of ingredients whose quality, safety and suitability for use in such medicines have been evaluated. The approved list of ingredients can be found in the Therapeutic Goods (Permissible Ingredients) Determination.

Major changes

A complete list of the 40 involved ingredients is shown in the table below:

Substance name	Status	Major change
ceramide 6 II	Addition	The specific requirements for this ingredient are as below: Ceramide 6 II must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 0.011%.
sodium lauroyl lactylate	Addition	The specific requirements for this ingredient are as below: Sodium lauroyl lactylate must: (a) Only be used in topical medicines for dermal application; and (b) Not be included in medicines intended for use on broken skin or in the eye. The concentration in the medicine must be no more than 0.2%.
theanine	Addition	The specific requirements for this ingredient are as below: Theanine must only be used in a medicine where Trans Chem Pty Ltd (Client ID 21878), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 March 2026. The route of administration for medicines that contain theanine must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 450 mg of theanine. The following warning statements (or words to the same effect) are required on the medicine label: - (PREGNT) "Not recommended for use by pregnant and lactating women"; - (ADULT) "Adults only".
neohesperidin-dihydrochalcone	Change	The Determination makes minor formatting changes and some other amendments to the specific; requirements for the ingredient, to permit oral use in listed and assessed listed medicines
Chelidonium majus	Change	The Determination makes minor amendments to these ingredients to reflect the transition periods expiration for requirements relating to those ingredients
Larrea tridentata	Change
valerian Dry	Change
valerian Powder	Change
Valeriana officinalis	Change
3'-sialyllactose sodium	Change	The Determination removes requirements for these ingredients to reflect the expiry of exclusive use periods for the relevant sponsors.
6'-sialyllactose sodium	Change
dihydrocapsiate	Change
hydrolysed chicken cartilage extract	Change
lacto-N-neotetraose	Change
lacto-N-tetraose	Change
hemp seed oil	Change	The Determination makes amendments to the specific requirements for this ingredient to align with the requirements in the Poisons Standard.
Curcuma aromatica	Change	The Determination makes revisions to add a liver injury warning statement and the maximum recommended daily doses for children based on age
Curcuma longa	Change
Curcuma zanthorrhiza	Change
Curcuma zedoaria	Change
curcumin	Change
Camellia sinensis	Change	The Determination makes revisions to add warning statements relating to liver injury, and to clarify the requirements for use as an excipient in flavour proprietary excipient formulations
benzophenone	Change	The Determination makes revisions to remove the use as an excipient ingredient in flavour proprietary excipient formulations
soy phosphatidylserine-enriched soy lecithin liquid	Change	The Determination makes revisions to amend the requirements regarding the maximum recommended daily dose, and remove the requirement that the concentration of soy phosphatidylserine must be no more than 15%.
soy phosphatidylserine-enriched soy lecithin powder	Change
Terminalia ferdinandiana	Change	The Determination makes revisions to clarify the requirements for the permitted plant part and preparation type when being used as an active ingredient
ethyl methacrylate	Change	The Determination updates the requirements for these ingredients to align with requirements in the Poisons Standard, and makes minor formatting changes and correction of minor typographical errors.
furfural	Change
C10-12 alkane/cycloalkane	Change
hydrogenated C6-14 olefin polymers	Change
turpentine oil	Change
lipase	Change
cetylpyridinium chloride	Change
artemisia oil	Change
zinc para-phenolsulfonate	Change
zinc stearate	Change
zinc valerate	Change
zinc lactate	Change
zinc lactate dihydrate	Change
Phleum pratense	Change

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